Clinical Research Associate, CRA

🔥 2 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites • Develops strong site relationships and ensures continuity of site relationships through all phases of the trial • Gains an in-depth understanding of the study protocol and related procedures • Performs clinical study site management/monitoring activities in compliance with ICH/GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated Documents • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner • Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance

🎯 Requirements

• Minimum 2 years of direct site monitoring experience in bio/pharma/CRO • Fluent in local languages and English (verbal and written) • Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines • Proven skills in Site Management including management of site performance and patient recruitment • Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices • Ability to understand and analyze data/metrics and act appropriately • Current driver’s license required

🏖️ Benefits

• Potential for flexible work arrangements • Professional development opportunities